JOINN’s pathology laboratory is a GLP-accredited, internationally certified and digitally advanced preclinical pathology platform. Centered on toxicity assessment, pharmacodynamic verification and global regulatory registration of innovative drugs, we deliver customized full-cycle pathological testing services compliant with NMPA, FDA, EMA regulations and INHAND global pathology guidelines. Backed by certified senior pathologists and whole-slide digital scanning system plus proprietary large-scale historical animal pathology database, we address technical challenges in special-administration studies, rare animal models and CGT product pathology. Globally accepted compliant pathology reports facilitate regulatory inspection and accelerate clinical translation of new medicines.
Preclinical pathology serves as the golden standard for evaluating drug-induced toxicity and therapeutic efficacy, which is a mandatory audit item by NMPA, FDA and EMA during drug registration inspection and directly determines the success of IND/NDA application.
With over a decade of industrial experience in preclinical pathology, JOINN has built a standardized, digitalized and GLP-compliant pathology platform led by ACVP, JSTP and CCVP board-certified veterinary pathologists. We are among China’s first CROs to conduct rodent carcinogenicity studies and specialized pathology assessment for unconventional administration routes.
Our lab adopts full-slide digital pathology workflow and peer-review diagnosis mechanism to eliminate subjective bias in traditional pathology reading. Supported by comprehensive historical background database covering conventional and rare laboratory species as well as Sino-US collaborative technical resources, we realize full traceability from tissue sampling, slide preparation, data analysis to final GLP report submission, supporting small-molecule, biologic, CGT and specialty-formulation drug development.
JOINN’s Pathology Laboratory builds a full closed-loop service chain of sampling, specimen processing, specialized assay, quantitative analysis and regulatory-compliant reporting. Adhering rigorously to GLP and global pathological diagnostic standards, it supports pathology tests for varied animal species, administration modes and all R&D stages, with full capabilities across general, special, molecular and ultrastructural pathology to serve all research scenarios from basic screening to advanced research.
| Service Item & Core Capabilities | |
| 3.1 Systematic Gross Necropsy across Species | Standardized SOP-driven necropsy for rodents, NHP, beagle, rabbit, transgenic/humanized animal, ferret and other rare species; systematic collection of target organs and lesion documentation to guarantee intact specimen quality. |
| 3.2 Standard Paraffin Tissue Processing | Fully automated tissue fixation, dehydration, embedding and sectioning to produce intact, uniform paraffin slides for downstream staining and molecular pathology testing with superior qualification rate. |
| 3.3 Routine HE Staining | As a fundamental core pathology technique, H&E staining is batch-processed on automated staining equipment for even coloration and superior contrast. It distinctly displays tissue and cellular features, lesion distribution and lesion damage, and is the gold-standard test for drug toxicity evaluation, tumor classification and tissue anomaly screening with consistent, traceable outcomes. |
| 3.4 Frozen Section Preparation | Low-temperature cryosectioning is used for delicate tissues such as fat, nerve and eye tissues and antigen-sensitive specimens. Sections can be rapidly produced free of dehydration and embedding to retain original tissue structure and bioactivity, ideal for urgent tests and specific immune labeling. |
| 3.5 Special Histochemical Staining | Custom staining solutions precisely stain collagen, elastic fibers, mucus, lipids and pathogens to distinguish tissue components and identify lesions, delivering dedicated diagnostic support for studies on fibrosis, inflammation, infection and metabolic abnormalities. |
| 3.6 Qualitative & Quantitative IHC Analysis | Following antigen antibody specific binding, all antibodies are VAR validated for species specificity to locate, qualify and quantify tissue target proteins. The method is commonly used in tumor classification, proliferation/apoptosis, immune infiltration and target expression studies with precise, consistent data. |
| 3.7 TEM/SEM Ultrastructural Specimen Preparation | Compliant with TEM and SEM testing standards, our professional sample processing covers fixation, dehydration, ultrathin slicing and heavy metal staining. Fine features such as cellular ultrastructure, impaired organelles and viral particles can be distinctly observed to support high-accuracy pathological evaluation. |
| 3.8 In Situ Hybridization (ISH) | Nucleic acid probe specific binding enables in-situ detection and expression profiling of genes, viral nucleic acids and mRNA. Target distribution is observable directly without nucleic acid isolation, ideal for advanced development of CGT, viral vector drugs and oncogene expression studies. |
| 3.9 Combined Pathology & Genetic Testing | Combining molecular and pathological techniques, we test gene expression, mutation and CNV in diseased tissues. By linking histological features to molecular changes, we thoroughly clarify drug efficacy and toxicity mechanisms and furnish molecular data for precision drug development. |
| 3.10 Digital Pathology Quantitative Morphometry | Equipped with digital whole-slide scanners and dedicated analytical software, we quantify lesion area, positive cell ratio, stain intensity and fibrous content. Manual subjective errors are avoided to deliver objective, numerical pathological assessment. |
| 3.11 Bone Marrow Cytology Evaluation | Standardized bone marrow smear, staining and microscopy workflows analyze nucleated cell proliferation, differential cell ratios and aberrant cell infiltration to accurately characterize drug effects on hematopoiesis, constituting a key component of hematotoxicity testing. |
ACVP/JSTP/CCVP-qualified pathologists follow INHAND criteria; multi-level peer review system ensures reliable diagnosis and registration-ready reports accepted by NMPA/FDA/EMA worldwide.
Centralized digital slide archiving, remote consultation and full-data traceability to satisfy regulatory audit requirements and improve diagnostic efficiency.
Early adopter of inhalation, ophthalmic and inner ear pathology testing; established proprietary ferret pathological database with mature experience in carcinogenicity and CGT pathology evaluation.
Strategic cooperation with top US toxicology pathology institutes to smoothly deliver dual NMPA/FDA registration projects including chronic toxicity and carcinogenicity studies.
Species-specific spontaneous lesion repository differentiates background changes from drug-induced toxicity and improves diagnostic accuracy significantly. To date, JOINN has conducted the most rodent carcinogenicity studies among CROs in China, with comprehensive historical tumor background data to fully support tumor analysis in long-term carcinogenicity assessments.
We cover conventional models (rodent, rabbit, dog, NHP) and rare/engineered animals (PDX, humanized mouse, ferret, guinea pig). Customized testing packages available for small molecule/biologic/CGT across oral/injectable/inhaled/ocular administration routes for toxicity, efficacy and carcinogenicity research.
All reports comply with GLP, INHAND, NMPA/FDA/EMA rules with complete audit trail and imaging archive for IND/NDA submission. Chinese & English bilingual reports provided to support global simultaneous registration and authority inspection support.
① All IHC antibodies pass species-specific verification in Veterinary Antibody Registry; ② Historical background lesion database separates spontaneous vs drug-caused lesions; ③ Board-certified pathologist panel; ④ Mandatory peer review procedure.
2–4 weeks for general toxicology pathology; 8–12 weeks for long-term carcinogenicity studies in mice; 5-6 months for long-term carcinogenicity studies in rats. Expedited project schedule upon client’s urgent request via parallel workflow and dedicated project manager arrangement.
Yes. Cross-modal data alignment between pathology, behavioral study, molecular biology and in-vivo imaging with 3D coregistration and multi-omics matching to generate integrated GLP analytical reports.
We have mature pathology platforms for ferrets, guinea pigs and other uncommon species, complete background data resources and specialist pathologists. Standardized, repeatedly validated testing meets all R&D and application needs.
Core Differentiators • Specimen-specific formalin fixation timed by tissue size for animal and clinical samples. • All IHC antibodies VAR-verified, exemplified by canine IL-6 and cynomolgus CD20.
Cross-Modal Data Analysis Platform • Spatiotemporal Correlation: 3D registration of digital pathology with micro-CT/PET; behavioral score–histopathology correlation modeling. • Multi-omics Connectivity: LCM-based paired transcriptomics/proteomics; R/Python tools for custom biomarker analysis. • Dynamic GLP Reports: Stage-by-stage pathological comparison + automated regulatory-compliant visuals.
